Effect of Antenatal Milk Expression on Breastfeeding Outcomes among Overweight and Obese Women

产前乳汁表达对超重和肥胖女性母乳喂养结果的影响

• 批准号: 10004136
• 负责人: Jill Radtke Demirci
• 金额: $ 38.72万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10004136
• 关键词: Achievement; Address; Adoption; Australia; Back; Birth; Body mass index; Breast Feeding; Caring; Child; Clinical Protocols; Collection; Complex; Control Groups; Data; Diabetes Mellitus; Dose; Education; Educational process of instructing; Endocrine; Enrollment; Epidemic; Exclusive Breastfeeding; Feeds; Formula supplementation; Future; General Population; Hand; Health; Home environment; Hospitals; Human Milk; Hypertension; Impairment; Infant; Infant Care; Instruction; Intention; International; Intervention; Interview; Labor Onset; Lactation consultant; Maintenance; Measures; Medical; Medical Records; Midwifery; Milk; Modeling; Modification; Morbidity - disease rate; Mothers; Nulliparity; Obesity; Outcome; Overweight; Participant; Pattern; Perception; Persons; Policies; Population; Postpartum Period; Pregnancy; Pregnant Women; Randomized Controlled Trials; Research; Risk; Risk Factors; Role; Sampling; Self Efficacy; Series; Subgroup; Surveys; Testing; Third Pregnancy Trimester; Time; Uterus; Visit; Weight; Woman; Women' s Group; Work; antenatal; attentional control; base; cardiometabolic risk; cardiometabolism; child bearing; clinical practice; critical period; design; diabetic; evidence base; experience; feeding; group intervention; hazard; improved; innovation; lactogenesis; milk expression; milk production; milk supply; milk volume; mortality; multi-site trial; neonatal outcome; non-diabetic; novel; obese mothers; postpartum weight; prepregnancy; treatment effect; two-arm study; uptake

PROJECT SUMMARY/ABSTRACT The purpose of this randomized controlled trial is to examine the impact of an antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among overweight and obese women, including impaired breastfeeding self-efficacy, insufficient milk supply (critical- period endocrine modulation of milk volume), and early formula supplementation in the context of a medically- complex birth (availability of banked antenatal milk). Although AME is increasing in popularity outside the U.S., there is a lack of evidence to support its widespread adoption among women both with and without risk factors for poor breastfeeding outcomes. In the proposed study, participants will be enrolled at 34-366/7 gestational weeks and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform trialed in our previous research; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). AME instruction or control group video education will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home. Specific aims are to: 1) determine the effect of the AME intervention on short-term breastfeeding outcomes, including breastfeeding self-efficacy and exclusivity, to two weeks postpartum; 2) to explore the sustained effect of the AME intervention on longer-term breastfeeding duration and exclusivity over the first year postpartum; and 3) to examine participants’ experiences with and perceptions of AME. Data for Aims 1 and 2 will be captured via medical record review and in-person and remote survey completion at enrollment and postpartum follow-ups at 2 weeks, 6 weeks, 12 weeks, 6 months, and 12 months postpartum. For Aim 3, maternal perceptions about and experiences with AME will be captured via in-depth interviews at 6 weeks postpartum. Using an intention- to-treat approach, generalized linear mixed-effects modeling and Cox proportional hazards regression will be used to examine the effect of treatment assignment (AME vs. control) on quantitative outcomes. Sensitivity analyses will be conducted to determine receipt and “dose” of AME on outcomes. We will also explore the role of maternal perception of milk supply and onset of lactogenesis II (copious milk production in the days following birth) in post-hoc mediational analyses. This project leverages our study team’s ongoing research investigating feasibility and preliminary efficacy of AME among normal weight and overweight/obese first-time mothers and feasibility of telelactation-delivered breastfeeding support. Results will inform clinical practice and policy regarding evidence-based breastfeeding support for overweight and obese women.

项目概要/摘要 这项随机对照试验的目的是检查产前乳汁表达 (AME) 的影响 干预与注意力控制条件对未产妇样本母乳喂养结果的影响 孕前体重指数 ≥ 25 的非糖尿病女性。AME 涉及挤奶和收集 在妊娠晚期，理论上可以解决母乳喂养的多重障碍 超重和肥胖的女性，包括母乳喂养自我效能受损、乳汁供应不足（严重- 经期内分泌调节乳汁量），以及在医学背景下早期配方奶粉补充 复杂的分娩（储存的产前母乳的可用性）。尽管 AME 在美国以外的地区越来越受欢迎， 缺乏证据支持其在有或没有风险因素的妇女中广泛采用 母乳喂养效果不佳。在拟议的研究中，参与者将在 34-366/7 妊娠期入组 周并分配到两个研究组之一：1）由远程、实时国际组织提供的 AME 教学 通过我们之前试验过的基于应用程序的创新远程哺乳平台获得委员会认证的哺乳顾问 研究;或 2) 注意力控制条件（与婴儿喂养无关的基于视频的婴儿护理教育）。 AME 指导或对照组视频教育将在 37 至 40 周的每周研究访问中进行 妊娠期间，干预组的女性每天在家继续 AME 1-2 次。具体目标是 目的： 1) 确定 AME 干预对短期母乳喂养结果的影响，包括 母乳喂养的自我效能感和排他性，直至产后两周； 2）探索持续效应 AME 对产后第一年的长期母乳喂养持续时间和纯母乳喂养的干预；和 3) 检查参与者对 AME 的体验和看法。目标 1 和 2 的数据将通过以下方式捕获 登记时进行病历审查、现场和远程调查完成以及产后随访 产后2周、6周、12周、6个月和12个月。对于目标 3，母亲的看法 AME 的经历将通过产后 6 周的深入访谈来记录。使用意图- 治疗方法、广义线性混合效应模型和 Cox 比例风险回归将 用于检查治疗分配（AME 与对照）对定量结果的影响。灵敏度 将进行分析以确定 AME 的接收和“剂量”对结果的影响。我们还将探讨这个角色 母亲对乳汁供应的感知和泌乳 II 的开始（在接下来的几天内产生大量乳汁） 出生）在事后中介分析中。该项目利用了我们研究团队正在进行的研究调查 AME 在正常体重和超重/肥胖的初产妈妈中的可行性和初步疗效 远程哺乳提供母乳喂养支持的可行性。结果将为临床实践和政策提供信息 关于对超重和肥胖妇女的循证母乳喂养支持。